Fadi Al-Rashid

Silent and Apparent Cerebral Ischemia After Percutaneous Transfemoral Aortic Valve Implantation A Diffusion-Weighted Magnetic Resonance Imaging Study

Background— The risk of stroke after transfemoral aortic valve implantation (TAVI) due to dislodgement and subsequent embolization of debris from aortic arch atheroma or from the calcified valve itself ranges between 2% and 10%. The rate of clinically silent cerebral ischemia is unknown but may be even higher. Methods and Results— Thirty-two patients who underwent TAVI with the use of a balloon-expandable (n=22) or self-expandable (n=10) stent valve prosthesis were included in this descriptive study and compared with a historical control group of 21 patients undergoing open surgical aortic valve replacement. Periprocedural apparent and silent cerebral ischemia was assessed by neurological testing and serial cerebral diffusion-weighted magnetic resonance imaging at baseline, at 3.4 (2.5 to 4.4) days after the procedure, and at 3 months. TAVI was successful in all patients. After the procedure, new foci of restricted diffusion on cerebral diffusion-weighted magnetic resonance imaging were found in 27 of 32 TAVI patients (84%) and were more frequent than after open surgery (10 of 21 patients [48%]; P=0.011). These lesions were usually multiple (1 to 19 per patient) and dispersed in both hemispheres in a pattern suggesting cerebral embolization. Volumes of these lesions were significantly smaller after TAVI than after surgery (77 [59 to 94] versus 224 [111 to 338] mm3; P<0.001). There were neither measurable impairments of neurocognitive function nor apparent neurological events during the in-hospital period among TAVI patients, but there was 1 stroke (5%) in the surgical patient group. On 3-month follow-up diffusion-weighted magnetic resonance imaging, there were no new foci of restricted diffusion, and there was no residual signal change associated with the majority (80%) of the foci detected in the periprocedural period. Conclusions— Clinically silent new foci of restricted diffusion on cerebral magnetic resonance imaging were detected in almost all patients (84%) undergoing TAVI. Although typically multiple, these foci were not associated with apparent neurological events or measurable deterioration of neurocognitive function during 3-month follow-up. Further work needs to be directed to determine the clinical significance of these findings in a larger patient population.

Cerebral Embolization During Transcatheter Aortic Valve Implantation A Transcranial Doppler Study

Background— Transcatheter aortic valve implantation (TAVI) is associated with a higher risk of neurological events for both the transfemoral and transapical approach than surgical valve replacement. Cerebral magnetic resonance imaging has revealed more new, albeit clinically silent lesions from procedural embolization, yet the main source and predominant procedural step of emboli remain unclear. Methods and Results— Eighty-three patients underwent transfemoral (Medtronic CoreValve [MCVTF], n=32; Edwards Sapien [ESTF], n=26) and transapical (ESTA: n=25) TAVI. Serial transcranial Doppler examinations before, during, and 3 months after TAVI were used to identify high-intensity transient signals (HITS) as a surrogate for microembolization. Procedural HITS were detected in all patients, predominantly during manipulation of the calcified aortic valve while stent valves were being positioned and implanted. The balloon-expandable ES prosthesis caused significantly more HITS (mean [95% CI]) during positioning (ESTF, 259.9 [184.8–334.9]; ESTA, 206.1[162.5–249.7]; MCVTF, 78.5 [25.3–131.6]; P<0.001) and the self-expandable MCV prosthesis during implantation (MCVTF, 397.1 [302.1–492.2]; ESTF, 88.2 [70.2–106.3]; ESTA, 110.7 [82.0–139.3]; P<0.001). Overall, there were no significant differences between transfemoral and transapical TAVI or between the MCV and ES prostheses. No HITS were detected at baseline or 3-month follow-up. There was 1 major procedural stroke that resulted in death and 1 minor procedural stroke with full recovery at 3-month follow-up in the MCV group. Conclusions— Procedural HITS were detected by transcranial Doppler in all patients. Although no difference was observed between the transfemoral and the transapical approach with the balloon-expandable ES stent valve, transfemoral TAVI with the self-expandable MCV prosthesis resulted in the greatest number of HITS, predominantly during implantation.

Vascular Access Site Complications after Percutaneous Transfemoral Aortic Valve Implantation

Background and Purpose:Transcatheter aortic valve implantation (TAVI) is a rapidly emerging treatment option for patients with aortic valve stenosis and high surgical risk. Different access routes have been proposed for TAVI including transapical, transsubclavian and transfemoral, with percutaneous transfemoral being the preferred because least invasive and nonsurgical. However, vascular access site complications due to the large-bore delivery catheters remain an important clinical issue, particularly with respect to the elderly patient collective typically considered for TAVI. In the study, the authors analyzed their 4-year TAVI experience with respect to vascular complications and their management in patients undergoing completely percutaneous transfemoral TAVI procedures.Patients and Methods:Since 2006, TAVI was performed in 101 consecutive patients at the West German Heart Center Essen. 33 patients underwent transapical TAVI, eight patients transfemoral TAVI with surgical access or closure, and 60 patients percutaneous transfemoral TAVI using two commercially available prosthetic valve devices.Results:Completely percutaneous TAVI was technically successful in all but one patient with malpositioning in the aortic arch during valve retrieval. There was no intraprocedural death and 30-day mortality was 12% (7/60). Vascular access site complications occurred in 19 patients (32%), necessitating surgical repair in six of them (10%). Complications included retroperitoneal hematoma (n = 2), iliac or femoral artery dissection (n = 10), (pseudo)aneurysm formation (n = 3), and closure device-induced vessel stenosis/ occlusion (n = 6). Of these, 13 cases could be managed either conservatively (n = 5) or by contralateral endovascular treatment (n = 8).Conclusion:Completely percutaneous TAVI has a high acute success rate with low intraprocedural and 30-day mortality. The patient collective appears to be prone to vascular complications which remain an important limitation of this novel technique. Although conservative or endovascular management is possible in the majority of cases, further technological developments are obliged to reduce the vascular complication rate.ZusammenfassungHintergrund und Fragestellung:Die katheterbasierte Aortenklappenimplantation ist eine neue, in der klinischen Routine bereits breit angewandte Therapieoption für Hochrisikopatienten mit kalzifizierter Aortenklappenstenose. Während in der Anfangsphase noch eine chirurgische Freilegung der arteriellen Zugangsgefäße und damit verbunden eine Vollnarkose nötig waren, ist die Durchführung heute in einer rein perkutanen Technik und somit sogar unter Analgosedierung möglich. Aufgrund der großen Kaliber der zur Einführung und zum Vorschieben der Prothese benötigten Schleusen und Katheter birgt diese Prozedur jedoch das Risiko einer Verletzung der arteriellen Zugangsgefäße, insbesondere da diese bei den betroffenen, älteren Patienten häufig atherosklerotische Veränderungen aufweisen. Die vorliegende Untersuchung gibt einen Überblick über die vaskulären Komplikationen und mögliche Managementstrategien an einem Kollektiv von 60 konsekutiven Patienten, bei denen in rein perkutaner Technik eine transfemorale Aortenklappenimplantation durchgeführt wurde.Patienten und Methodik:Seit 2006 wurde am Westdeutschen Herzzentrum Essen bei insgesamt 101 konsekutiven Patienten eine kathetergesteuerte Aortenklappenimplantation durchgeführt, bei 33 Patienten über den transapikalen, bei 68 Patienten über den transfemoralen Zugang. Während bei den initialen acht in transfemoraler Technik behandelten Patienten noch eine chirurgische Freilegung und/oder ein chirurgischer Verschluss der Zugangsgefäße durchgeführt wurde, erfolgte die Implantation der ballonexpandierbaren Edwards-Sapien- (n = 41) und der selbstexpandierbaren CoreValve-Prothese (n = 19) bei de hemofolgenden 60 Patienten in rein perkutaner Technik unter Verwendung von Nahtverschlusssystemen.Ergebnisse:Bis auf eine Fehlpositionierung im Aortenbogen konnten alle Aortenklappenprothesen erfolgreich in rein perkutaner Technik und ohne intraprozeduralen Todesfall implantiert werden. Die 30-Tage-Mortalität betrug 12%. Postinterventionell zeigte sich eine signifikante Verbesserung der Hämodynamik mit Abfall des mittleren transaortalen Druckgradienten von 52 ± 18 auf 13 ± 6 mmHg und einer Zunahme der Klappenöffnungsfläche von 0,6 ± 0,2 auf 1,5 ± 0,3 cm2. Die Rate an vaskulären Komplikationen betrug 32% (19 von 60 Patienten). Die Komplikationen beinhalteten zwei retroperitoneale Hämatome, zehn Dissektionen der Femoral- und Iliakal gefäße, drei Aneurysmabildungen und sechs ver schluss systeminduzierte Komplikationen. In fünf Fällen erfolgte eine konservative Therapie, bei acht Patienten konnte eine katheterinterventionelle Behandlung durchgeführt werden. Eine operative Sanierung war bei sechs Patienten (10%) nötig.Schlussfolgerung:Die transfemorale Aortenklappenimplantation kann heutzutage in rein perkutaner Technik mit einer hohen Erfolgsrate, geringer Mortalität und guten hämodynamischen und klinischen Ergebnissen durchgeführt werden. Vaskuläre Komplikationen sind jedoch noch häufig und stellen eine wichtige Limitation dieser neuen Technik dar. Obwohl ein konservatives oder interventionelles Management dieser Komplikationen in der Regel möglich ist, müssen zukünftige Weiterentwicklungen in besonderem Maße auch auf eine Reduktion der vaskulären Komplikationsrate gerichtet sein.

Incidence, outcome and correlates of residual paravalvular aortic regurgitation after transcatheter aortic valve implantation and importance of haemodynamic assessment.

AIMS Residual paravalvular aortic regurgitation (PAR) after transcatheter aortic valve implantation (TAVI) is common. We therefore evaluated incidence, determinants and outcome of PAR after TAVI. METHODS AND RESULTS Data from 167 consecutive transcatheter TAVI patients were analysed. PAR was graded by angiography and the pressure gradient between diastolic aortic pressure and left ventricular end-diastolic pressure (∆PDAP-LVEDP) after implantation. TAVI was technically successful in all patients. Mortality was 9% and 20% at 30 days and one year, respectively. Post-procedural PAR was absent in 54 patients (32.3%). Mild PAR was found in 89 (53.3%), moderate in 21 (12.6%), and moderate-to-severe in three patients (1.8%). Cardiovascular mortality at 30 days and one year was increased in patients with moderate and moderate-to-severe PAR compared to patients with no and mild PAR (46% vs. 4% and 73% vs. 7%, respectively, p<0.001). Receiver operating characteristic curve analysis suggested ∆PDAP-LVEDP ≤18 mmHg as a novel predictor of mortality, with an area under the curve of 0.97. CONCLUSIONS In patients undergoing TAVI, moderate and moderate-to-severe PAR was observed in 14.4% and associated with increased cardiovascular mortality. A pressure gradient ∆PDAP-LVEDP≤18 mmHg carries adverse prognosis and requires further intervention.

Preparatory Balloon Aortic Valvuloplasty During Transcatheter Aortic Valve Implantation for Improved Valve Sizing

OBJECTIVES This study sought to evaluate whether supra-aortic angiography during preparatory balloon aortic valvuloplasty (BAV) improves valve sizing. BACKGROUND Current recommendations for valve size selection are based on annular measurements by transesophageal echocardiography and computed tomography, but paravalvular aortic regurgitation (PAR) is a frequent problem. METHODS Data of 270 consecutive patients with either conventional sizing (group 1, n = 167) or balloon aortic valvuloplasty-based sizing (group 2, n = 103) were compared. PAR was graded angiographically and quantitatively using several hemodynamic indices. RESULTS PAR was observed in 113 patients of group 1 and 41 patients of group 2 (67.7% vs. 39.8%, p < 0.001). More than mild PAR was found in 24 (14.4%) patients of group 1 and 8 (7.8%) patients of group 2. According to pre-interventional imaging, 40 (39%) patients had a borderline annulus size, raising uncertainty regarding valve size selection. Balloon sizing resulted in selection of the bigger prosthesis in 30 (29%) and the smaller prosthesis in the remaining patients, and only 1 of these 40 patients had more than mild PAR. As predicted by the hemodynamic indices of PAR, mortality at 30 days and 1 year was less in group 2 than in group 1 (5.8% vs. 9%, p = 0.2 and 10.6% vs. 20%, p = 0.01). CONCLUSIONS Preparatory balloon aortic valvuloplasty during transcatheter aortic valve implantation improves valve size selection, reduces the associated PAR, and increases survival in borderline cases.

Thoracic aortic aneurysm expansion due to late distal stent graft-induced new entry

This study analyzed the mechanism and risk factors of thoracic aortic aneurysm expansion due to late distal stent graft‐induced new entry (dSINE).

Comparison Between Different Risk Scoring Algorithms on Isolated Conventional or Transcatheter Aortic Valve Replacement

BACKGROUND There are a number of scoring systems for risk evaluation in cardiac surgery, the most important of which are the European System for Cardiac Operative Risk Evaluation (EuroSCORE), The Society of Thoracic Surgeons (STS) score, the ACEF score (acronym for age, preoperative creatinine, and ejection fraction), and more recently, the new EuroSCORE-II. The aim of our study was to analyze and compare the predictive value of these scores in patients undergoing aortic valve replacement (AVR) or transcatheter aortic valve replacement (TAVR). METHODS A total of 1,512 consecutive patients undergoing either conventional AVR (n = 1,066) or TAVR (transfemoral, n = 291; transapical, n = 155) were enrolled. Logistic and additive EuroSCORE of all patients were 13.3% ± 13.2% and 7.8% ± 3.3%, on average. The mean STS score, ACEF score, and EuroSCORE-II were 5.7% ± 5.0%, 1.5% ± 0.7%, and 4.2% ± 4.9%, respectively. RESULTS Overall mortality at 30 days was 6.3%. The area under the curve (AUC) was 73.8 for the logistic EuroSCORE and 73.5 for the additive EuroSCORE. The STS score gave an AUC of 70.8. The AUCs for the ACEF and EuroSCORE-II were 63.8 and 71.2, respectively. In the transfemoral TAVR group, AUCs were 59.8 and 59.3 for the logistic and additive EuroSCORE, respectively, 63.2 for the STS score, and 55.9 and 55.4 for the ACEF and EuroSCORE-II, respectively. In the transapical TAVR group, AUCs were 88.0 and 82.8 for the logistic and additive EuroSCORE, respectively, 79.0 for the STS score, and 61.7 and 83.7 for the ACEF and EuroSCORE-II, respectively. CONCLUSIONS Overall, 30-day mortality was best predicted by the STS score. Discrimination threshold predicting mortality was equal between all other risk calculators. Surprisingly, the new EuroSCORE-II was not superior to other models in risk prediction for AVR and TAVR patients.

Suture-mediated arterial access site closure after transfemoral aortic valve implantation.

To evaluate feasibility, safety and efficacy of percutaneous arterial access site closure after transfemoral, transcatheter aortic valve implantation (TF‐TAVI) using a single, commercially available six French monofilament suture‐mediated vascular closure device (VCD) in “preclosure” technique.

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve.

BACKGROUND We evaluated the clinical and hemodynamic performance of the new balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA) transcatheter heart valve (S3 THV). METHODS Between April 2013 and January 2015, 54 consecutive high-risk patients presenting with aortic stenosis were treated with the new S3 THV. Clinical and hemodynamic data as well as device and procedure variables were obtained at baseline, intraoperatively and at 30-days according to Valve Academic Research Consortium-2. RESULTS The S3 THV was implanted in 41 patients (44% female) via transapical access and in 13 patients via transaortic access. Patients were a mean ± standard deviation age of 80.3 ± 6.0 years. The mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of all patients was 33.3% ± 13.4%, the mean The Society of Thoracic Surgeons Score was 6.7% ± 5.3%, and the mean EuroSCORE II was 7.0% ± 5.5%. All patients underwent successful implantation (23 mm, n = 12; 26 mm, n = 22; 29 mm, n = 20), without any intraprocedural complications or repeat ballooning. At 30 days, 53 patients (97.8%) showed no or mild paravalvular aortic regurgitation, 1 patient (2.2%) showed moderate regurgitation, and no patients had more than moderate postprocedural aortic regurgitation. Stroke incidence was 3.7% (2 of 54), and all-cause mortality was 3.7% (2 of 54, sepsis and multiorgan failure). Two patients required a new pacemaker. At 30 days, all patients were in New York Heart Association Functional Class I or II, and the mean pressure gradients were 10.8 ± 3.6 mm Hg. CONCLUSIONS The present study shows excellent clinical and hemodynamic outcomes of high-risk transapical valve replacement patients treated with the new S3 THV. The S3 THV shows a low incidence of postoperative aortic regurgitation, with 98% presenting with less than mild aortic regurgitation.

Conventional aortic valve replacement or transcatheter aortic valve implantation in patients with previous cardiac surgery.

BACKGROUND Clinical outcomes were compared among patients with previous cardiac surgery undergoing transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (AVR). METHODS Between 2007 and 2014 a total of 142 consecutive patients with previous cardiac surgery were treated by TAVI either by the transfemoral (n=68) or transapical access (n=74), and 236 patients underwent a surgical redo-AVR. Of these patients, propensity analysis (m:n) matched 62 (group 1, TAVI) and 51 patients (group 2, redo-AVR). A multivariate logistic regression model was constructed. Moreover, mortality was compared between both groups by Cox regression. RESULTS Both groups differed significantly (p<0.01) in regard to age and preoperative risk scores (EuroSCORE and STS-Score). Thirty-day mortality was 14.5% (9/62) in group 1 and 5.8% (3/51) in group 2 (p=0.23). Risk-adjusted multivariable analysis revealed only the logistic EuroSCORE to be strongly correlated with 30-day mortality (p=0.01). Multivariate analysis showed no difference in 30-day mortality between both groups (p=0.21). Multivariate Cox regression revealed New York Heart Association functional class (p=0.001), logistic EuroSCORE (p=0.01), and STS-Score (p=0.03) to be strongly associated with overall mortality. Moreover, evaluating overall mortality, Cox regression showed no difference between both groups (p=0.36). CONCLUSIONS The present study shows that in patients with cardiac reoperation, TAVI comes with similar outcomes when compared to surgical AVR. On the other hand, conventional redo-AVR is still a valuable and safe treatment option.